Get AI-powered advice on this job and more exclusive features.Main Activities And ResponsibilitiesConducting process validation activities on medical devices for product categories bags for parental nutrition , as well as on other company assets (cleanroom and sterilization) at our facility and those carried out at external suppliers.Performing activities related to CSV (Computer Software Validation) and TMV (Test Method Validation).Basic knowledge of Radiofrequency welding , assembling and packagingPlanning and executing tests on the product subjected to process validation when necessary.Effectively interacting with R&D, product V&V, and Operations teams to ensure the maintenance of processes and products according to design and specifications.Collaborating with design transfer and product industrialization teams to ensure the correct transfer of device design into production.KnowledgeDegree in Engineering or scientific subjects.Minimum 2 years of experience in the role or similar roles (such as production or validation engineer).Knowledge of validation strategy and management of validation documents necessary for process validation (IQ – OQ – PQ).Knowledge of statistical tools: DOE study, Gage R&R, capacity analysis (Cp, Cpk, Pp, Ppk), definition of sampling size preferably using Minitab software.Good level of English.Basic knowledge of project managementSkillsTeamworkProblem SolvingAdaptabilityCritical ThinkingAutonomySeniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionManagement and ManufacturingIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at B. Braun Group by 2xSant’Agata Bolognese, Emilia-Romagna, Italy 1 day agoLuzzara, Emilia-Romagna, Italy 2 weeks agoMirandola, Emilia-Romagna, Italy 1 month agoSVP, Head of Cell Therapy GMP Manufacturing & Process Development (all genders)We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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